Identity
- Trade Name
- Integrated Cyler (110V) FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Model / Reference
- MOL1001 FDA UDI
Identifiers
- Catalog Number
- MOL1001 FDA UDI
- Primary DI / UDI-DI
- 10816101025005 FDA UDI
- 510(k) Number
- K102314 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Integrated Cyler (110V) by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102314 also covers:
- Direct Amplification Disc — DiaSorin Molecular LLC
- Direct Amplification Disc — DiaSorin Molecular LLC
- Direct Amplification Disc Kit — DiaSorin Molecular LLC
- Integrated Cycler (220V) — DiaSorin Molecular LLC
- Integrated Cycler (220V) Pre-Owned — DiaSorin Molecular LLC
- Integrated Cyler (110V) Pre-Owned — DiaSorin Molecular LLC
- Simplexa™ Spectral Calibration Panel — DiaSorin Molecular LLC
- Universal Disc — DiaSorin Molecular LLC
- Universal Disc — DiaSorin Molecular LLC
- Universal Disc Cover Tape — DiaSorin Molecular LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 6047fe36-d67f-4666-b9f3-31d4957b6138 36 fields · synced Jun 9, 2026